Effect of Sevoflurane and Propofol on Hepato-splanchnic Pressure and Flow During Hepatobiliary Surgery

NCT03772106 | Completed Phase 4 DMC

• 1 other identifier: 2017/0164
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Blood loss in hepatobiliary surgery is correlated with an increase in postoperative complications (e.g. transfusion related lung injury and tumor recurrence) and reduced longterm survival. To reduce morbidity and mortality in hepatobiliary surgery, modulation of the hepato-splanchnic blood flow and pressure is used. In liver surgery pharmacological modulations are widely used to prevent blood loss. For pharmacological modulation central venous pressure is commonly used to reduce the pressure in the inferior vena cava, however little is known about pharmacological effect on blood flow in the hepatic artery and portal vein. The modulation of the hepato-splanchnic blood flow can also play an important role, not only for prevention of blood loss but also for survival of the organs (e.g. ischemic injury due to low flow). Volatile anesthetics induce a dose-dependent reduction of the hepato-splanchninc blood flow. Propofol however, increases hepatic blood flow when compared with volatile anesthetics. Pharmacological modulation of hepato-splanchnic bloodflow with anesthetics such as sevoflurane or propofol can play an important role in modulation of ischemia/reperfusion injury and survival of organs. The aim of the study is to determine and to compare the effect of sevoflurane versus propofol on hepatosplanchnic pressure and hepato-splanchnic blood flow during hepatobiliary surgery.

Conditions

General Anesthesia

Keywords

hepato-splanchnic blood flow

Outcome Measures

Primary Outcomes (1)

• Change in blood flow in hepatic artery and main portal vein

  flow/pressure measurements with echo probe and needle

  From randomization until the end of the whipple surgery

Secondary Outcomes (3)

• need of inotropic and/or vasopressor support

  From start anesthesia until end of anesthesia

• amount of blood loss

  From start of surgery until end of surgery

• amount of colloids given during surgery

  From start of surgery until end of surgery

Study Arms (2)

Group P

EXPERIMENTAL

Group P : Propolipid 1% dose : variable to keep BIS between 40 and 60

Drug: Propofol Fresenius

Group S

EXPERIMENTAL

Group S : Sevoflurane dose : variable to keep BIS between 40 and 60

Drug: sevorane

Interventions

Propofol Fresenius DRUG

Propolipid 1% : IV

Group P

sevorane DRUG

sevorane Quick fill (sevoflurane) : inhalation

Group S

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ≥ 18 years (Female or Male)
• ASA I - II - III
• Able to comprehend, sign and date the written informed consent document to participate in the clinical trial.
• Scheduled for hepato-biliary surgery.

You may not qualify if:

• Allergy for the medication
• Renal insufficiency (SCr \> 2 mg/dl)
• Severe heart failure (EF \< 25%)
• Hemodynamic instable patients
• Arterial fibrillation
• Sepsis
• BMI \> 40
• Severe coagulopathy (INR \> 2)
• Thrombocytopenia (\< 80 x 10³ /µL)
• History of severe postoperative nausea \& vomiting

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (1)

• van Limmen J, Wyffels P, Berrevoet F, Vanlander A, Coeman L, Wouters P, De Hert S, De Baerdemaeker L. Effects of propofol and sevoflurane on hepatic blood flow: a randomized controlled trial. BMC Anesthesiol. 2020 Sep 22;20(1):241. doi: 10.1186/s12871-020-01150-3.

  PMID: 32962657 DERIVED

MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Jurgten Van Limmen, MD

  UZ Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 11, 2018
• Study Start: June 8, 2017
• Primary Completion: January 27, 2018
• Study Completion: December 4, 2018
• Last Updated: December 11, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)